Efficacy of acupuncture in the treatment of post-stroke depression: A study protocol of a randomized controlled trial.

ABSTRACT

INTRODUCTION: Post-stroke depression (PSD) is an emotional disease characterized by loss of interest and depression after a stroke. Acupuncture, one of the most critical non-drug therapies for the treatment of PSD, has significant clinical efficacy, but the mechanism is not fully understood. Previous study has shown that acupuncture can reduce the level of proinflammatory cytokines and increase the level of anti-inflammatory cytokines, suggesting that regulating the dynamic balance of inflammatory cytokines may be the basis for acupuncture to improve PSD symptoms. METHODS AND ANALYSIS: A total of 84 patients with PSD will be recruited and randomly assigned to one of two groups at a 11 ratio. Based on the conventional stroke treatment, the control group will receive XingnaoKaiqiao (XNKQ) acupuncture, and the experimental group will receive antidepressant acupuncture at the same time as XNKQ acupuncture. The intervention will last four weeks, and data will be collected before and after treatment. The Hamilton depression scale (HAMD-17) is the primary outcome measure, and the secondary outcome measures include the Self-rating Depression Scale (SDS), the National Institute of Health stroke scale (NIHSS), and the Modified Barthel Index (MBI). Serum IL-1ß, IL-4, 5-HT, and BDNF will be used as laboratory indicators. The scales will be assessed at baseline, two weeks, and four weeks, and serum items will be measured at baseline and four weeks after treatment. This study will observe the clinical effect of acupuncture on PSD and the changes in serum-related inflammatory cytokines and explore the possible mechanism of acupuncture against depression from the perspective of inflammatory response. ETHICS AND DISSEMINATION This study protocol was approved by the Medical Ethics Committee of the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (item number TYLL2023[Z]004). Findings of the trial will be disseminated through peer-reviewed journals and scientific conferences.